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临床试验/NCT05392491
NCT05392491已完成不适用

The Brazilian Coronary Disease Cohort

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 4,004 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,004
试验地点
1
主要终点
Number of participants with Composite Outcome

研究概览

简要总结

Although coronary artery disease may have a stable chronic clinical course, it is known that this reality does not apply to atherosclerotic plaques, they can grow, complicate, stabilize and again start new cycles of growth/destabilization/stabilization or quiescence in the presence or absence of symptoms. While in obstructive coronary lesions there are well-founded guidelines based on multiple clinical studies, in relation to investigation and treatment; on the other hand, in non-obstructive lesions, there are no such guidelines. There are gaps in the knowledge about the prognostic implications of minor injuries and the occurrence of events. This study seeks precisely to fill these knowledge gaps. Of particular relevance are the large number of patients (approximately 10,000 patients) and the long clinical follow-up, that is, in eight years.

详细描述

Introduction:

For decades, patients with obstructive coronary disease, specifically with lesions above 70%, have been the subject of numerous randomized studies and meta-analyses concerning the influence of drug treatments, revascularization (surgical or percutaneous), and lifestyle on their prognosis. In this scenario, the investigators already have a reasonable knowledge of the behaviors most appropriate for both avoiding events and alleviating symptoms. However, one particular subgroup consists of patients whose lesions are non-obstructive. In most cases, these are considered lesions of ≤70%. Many individuals presented obstructive lesions that were deemed appropriate for angioplasty within this classification. For example, in the study Defer of 325 patients with indications of ischemia, 44.3% presented FFR (fractional flow reserve) ≤0.75, which suggested significant obstruction, and were submitted to ATC. Thus, the investigators consider the threshold ≤70% inappropriate since it includes many patients with ischemia when assessed by FFR. Therefore, this study has decided to investigate patients with lesions of ≤50% on the supposition that they do not have obstructive lesions. In addition, although coronary disease may follow a stable clinical course, this is not the case with atherosclerotic plaques. These can grow, become complex, stabilize and reinitiate new cycles of growth/destabilization/stabilization or inactivity, in either the presence or absence of evident symptoms. Though aware of this dynamic, studies were performed to "photograph" at a given time subclinical atherosclerotic load and correlate it to the incidence of the events. The indicators most used for evaluating atherosclerotic load have been the presence of extra-cardiac atherosclerosis (carotid ultrasound) and calcification of the coronary arteries. Furthermore, the calcium score has been used for the same purpose in the Brazilian population: but only as a prognostic indicator among carriers of family hypercholesterolemia. However, there are considerable doubts concerning therapeutic interventions in asymptomatic patients with no critical stenosis. Given this gap, chiefly among the Brazilian population, and being an institution with one of the highest volumes of medical care and screening for coronary disease globally, the investigators have all the necessary conditions to put this important public health problem into perspective.

Objectives:

To evaluate clinical evolution, in eight years, of patients with no coronary lesions or lesions <50%, invasive coronary angiography (ICA) exams or coronary angiotomography is performed for the diagnosis of coronary disease.

Population:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to Instituto do Coração (InCor HC, FM-USP) for invasive coronary angiography or angiotomography.

排除标准

  • Age under 18 years or over 80 years at the time of examination;
  • Previous history of acute coronary syndrome (infarction and unstable angina);
  • Revascularization interventions (surgical or percutaneous);
  • Valvular heart disease;
  • Cardiomyopathies;
  • Diseases with a poor prognosis (expected survival of less than 8 years).

结局指标

主要结局

Number of participants with Composite Outcome

时间窗: 8 years

Participants presenting the following outcomes: death of any cause, acute myocardial infarction, stroke, and need for revascularization.

次要结局

  • Number of participants with acute myocardial infarction(8 years)
  • Number of participants needing revascularization(8 years)
  • Number of participants with stroke(8 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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